A few days ago, we were contacted by a Swiss company (therefore company is based outside the EU). They wanted to know if BENS Consulting could generate UFI codes for them in our own name?
Our answer was unfortunately NO, BENS Consulting can’t do that.
Commission Regulation 2017/542 states that information concerning mixtures classified as dangerous based on their health or physical effects must be provided by an importer or downstream user established in the European Economic Area. That means companies based in the European Union, Norway, Iceland and Liechtenstein.
Our company is established in Slovenia, i.e. within the EU, but we are not an importer or exporter or downstream user (downstream user is the person using the substance in his industrial or professional activity, or the manufacturer of the mixture/formulator).
So, what does this mean for products that enter the EU market and have been manufactured outside the EU? Are they also subject to the requirements of generating UFI code and reporting data to Poison Centres?
YES, they are also subject to exactly the same requirements as products manufactured in the EU.
The difference is that companies established outside the European Economic Area cannot fulfil these obligations on their own. These obligations have to be ensured by the importers - EU-based companies. The company that puts the product first on the EU market (in this case the importer) must ensure:
- that the label does have the UFI code and
- to report data to Poison Centres for all countries where the product is placed on the market are met.
Do you have any questions regarding UFI obligations? Send them to me and I’ll see if can help you in any way.